|Publication number||US7597847 B2|
|Application number||US 10/403,266|
|Publication date||Oct 6, 2009|
|Filing date||Mar 31, 2003|
|Priority date||Mar 31, 2003|
|Also published as||CA2462484A1, CA2462484C, CN1534298A, CN1534298B, DE602004015522D1, EP1464963A2, EP1464963A3, EP1464963B1, US20040191121|
|Publication number||10403266, 403266, US 7597847 B2, US 7597847B2, US-B2-7597847, US7597847 B2, US7597847B2|
|Inventors||David Angelo Tomasso, Raymond Francis Jakubowicz, James Vanselow Barry|
|Original Assignee||Ortho-Clinical Diagnostics, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (57), Non-Patent Citations (41), Classifications (17), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
1. Field of the Invention
The present invention relates to a stationary probe for an analyzer. In particular, the present invention relates to a desktop analyzer having a stationary probe for aspirating or dispensing a liquid.
2. Description of the Related Art
Desktop analyzers, particularly for veterinary use and point of care (POC) human use, are known in the art. For example, the Abaxis Vetscan™ and Hemagen Analyst™ are both desktop analyzers for veterinary use. The Vitros DT-60™ is a desktop analyzer manufactured by Ortho-Clinical Diagnostics Corp. Other known analyzers include those POC analyzers described in U.S. Pat. Nos. 5,968,329, 5,747,666, 5,980,830, and 5,787,015, all of which are incorporated by reference in their entireties. U.S. Pat. No. 4,965,049 also discloses a modular analyzer system. U.S. Pat. No. 5,983,734 discloses a modular automated diagnostic system. U.S. Patent Application Publication No. 2002/0098116 ('116 publication) describes a biochemical analysis system. U.S. Pat. No. 4,797,257 describes analyzers and their components that use slides as test elements. U.S. Pat. No. 5,314,825 discloses a chemical analyzer having a rotary cuvette holder and a pivoting probe. These publications are also incorporated by reference in their entireties.
Known diagnostic systems, such as those described above, have generally adequately addressed size issues but often at the expense of functionality, test menu, and productivity. Most known systems perform tests serially on a single patient sample, significantly limiting walk away time for the user to perform other work tasks. These analyzers usually employ a number of dedicated subsystems within the analyzer to perform discrete functions such as sample storage and positioning, reagent storage, and waste collection among others. In some cases, multiple analyzer systems are required to perform the variety of test menus needed in the lab, for example, separate systems to perform immuno rate or electrolyte assays.
In many known systems, whole blood samples must be prepared (e.g., diluted or centrifuged) prior to testing, further limiting the users productivity. Reagent formats can be individual test strips (e.g., such as dry-slide technology), which offer the most cost effective solution and test flexibility, or multiple test formats (e.g., such as the Abaxis Vetscan™ rotor), which limit selective assay testing, and, as a result, drive up test costs. Liquid systems may compromise analytical performance when dealing with patient sample background interference compared to analyzers that use a dry-slide format. However, there are some tests which are incompatible with dry formats and therefore must use wet or liquid formats.
There is a need for small, portable in vitro diagnostic systems that are capable of automatically performing a wide range of analysis, preferably for both human and animal health care providers, and provide the flexibility to execute a variety of operations on patient samples with a high degree of simplicity and cost effectiveness. There are a number of factors that drive the need for improved products including:
Cost Pressures—Lower cost testing solutions that more effectively utilize system reagents and operation.
Ease of Use—Users at the POC and veterinary labs are often less skilled than most technicians working in large lab operations and often perform a wide range of lab and office functions. Systems utilized in these labs must be simple to use but offer a high degree of functionality. Systems that are easy to use with little maintenance or preparation of both sample and instrument are advantageous.
Increased Test Menu Capability—Systems are needed that can perform a wide range of tests without compromising analytical performance due to test format limitations. Current systems penalize the user due to their inflexibility to accommodate individual and panel tests without additional reagent waste associated with pre-configured test formats (e.g., the Abaxis Vetscan™ rotor or the Hemagen Analyst™ Panels+test rotor).
Size—Lab space is often very limited and portability is often a factor allowing the analyzer to be used at the patient location.
In developing such systems that achieve the above factors, there is a need to minimize the number of moving parts to save on costs and minimize space requirements. Known analyzers often use moving probes (e.g., U.S. Pat. Nos. 4,965,049 and 6,013,528 and the '116 publication) to align the probe with the test element, such as a well or slide, in order to dispense or aspirate the fluid being analyzed or assayed. Moving probes can also be used to aspirate and dispense diluent, reagent, wash and reference fluids. In some instances, the probes must be aligned precisely with the target receptacle. This results in expensive and space consuming motors, transmissions and control systems.
One object of the invention is to overcome the disadvantages of the known art described above. Another object of the invention is to provide a desktop analyzer that can perform an array of different analysis within a compact space. Another object of the invention is to provide a stationary multifunction probe for an analyzer. Yet another object of the invention is to provide a method of dispensing or aspirating a fluid into a test element that includes using a stationary probe. Yet another object of the invention is to provide a method of analyzing a sample.
The foregoing and further objects of the invention are accomplished according to one aspect of the invention that provides an analyzer that includes: a stationary probe capable of dispensing or aspirating a liquid; one or more of a movable test element or movable liquid source; and a conveyor for moving the movable test element or liquid source with respect to the stationary probe. In a preferred embodiment, the conveyor includes a dual rotor conveyor. In another preferred embodiment, the analyzer is a desktop analyzer.
According to another aspect of the invention, there has been provided a method of dispensing or aspirating a liquid into and/or onto a test element that includes: providing a movable test element having identifying marks, such as a barcode, thereon and a movable sample liquid supply; providing a stationary probe; reading the identifying marks to determine which test is to be performed and optionally the dimensions of the test element; moving the movable sample liquid supply into registration with the probe; aspirating sample into the stationary probe; and moving the movable test element into registration with the probe, wherein the registration of the test element with the probe is controlled by the test to be performed. In a preferred embodiment, the method is implemented by a computer program interfacing with a computer.
According to another aspect of the invention, there has been provided an article of manufacture comprising a computer usable medium having computer readable program code configured to conduct the method described above.
Further objects, features and advantages of the present invention will be apparent to those skilled in the art from detailed consideration of the preferred embodiments that follow.
The present invention is directed to an in vitro analyzer for use in human and animal diagnostics. The analyzer of the present invention allows for simplified panel testing, e.g., a “chem 7” or “chem 20” panel, with the option to add individual tests as required by the user without generating unnecessary reagent waste or unwanted tests. The device is simple to use and allows the user the opportunity to place multiple patient samples on the device that will automatically process the tests without further intervention by the user.
In order to make such a compact design possible, one aspect of the present invention provides an analyzer that includes a stationary fluid probe and movable test element(s) or movable fluid, preferably liquid, supply(ies). An important feature of the invention is the stationary probe. The stationary probe preferably is a probe, such as a nozzle capable of aspirating and/or dispensing a liquid, preferably in a metering fashion. As used herein, “stationary” is defined as the probe being stationary along at least one axis of an x, y and z coordinate system. Preferably, the probe is only movable along a single axis, such as the vertical “z” axis. Movement in the vertical direction allows the probe to access tips, samples, waste, etc., which may be at different heights. Thus, with the exception of vertical movement of the probe, all movement is confined to the movable test element, which in some embodiments is transported by a moving rotor. This has the significant advantage over typical known analyzers in that additional cost and complexity that would result from a probe transport system is avoided. That is, a simple control system in one dimension (in this case vertical) is all that is required for the stationary probe, as opposed to a more complex control system required for more degrees of freedom. Thus, instead of a complex transport and control systems as used in known analyzer probe transports (i.e., multiple servo motors and controllers being provided), a much simpler transport and control system is all that is required.
Preferably, the probe includes a probe or metering tip, preferably disposable, that actually contacts the fluid being manipulated. In one embodiment, an additional probe, such as a reference fluid dispensing nozzle, may also be provided. Due to space limitations, it may be desirable to have some movement of the additional probe, such as to move from a fluid source, e.g., a source of reference fluid, to the dispense position over the test element. In such an instance, the movement of the additional probe could be limited to movement in a straight line or a single plane, due to the position of one opening of the probe guide (described below), which would be located to receive the additional probe. This would simplify construction by dispensing with the requirement of providing motion and control systems for three dimensional movement.
In order to make such a compact design further possible, one embodiment of the present invention also provides a test element holder, such as a test element cartridge, that includes a guide for positioning a fluid probe, such as an aspirating or dispensing nozzle with a test element or fluid source being acted upon. Further details of the test element cartridge and a guide can be found in copending application entitled “Test Element Holder with a Probe Guide for an Analyzer”(Ser. No. 10/403,153) filed concurrently herewith and incorporated by reference in its entirety.
The test element can be a slide containing the reagents necessary for the analysis, the so-called dry-slide technology as described in U.S. Pat. No. 4,797,257 or a cup-shaped well as described in U.S. Pat. No. 5,441,895, which are incorporated by reference in their entireties. The test element can also be the so-called test strip chemistry.
Broadly, the test element holder contains test elements to be dispensed. Typically this would include multiple test elements, however, in some embodiments, such as wells for a wet analysis, it can be envisioned that a single test element may be employed. The holder can also be termed a cassette. The holder includes a body portion for holding at least one test element and a guide adapted to receive a probe to position the probe in a desired registration with the test element. Preferably, the test element holder includes a recess for holding the test elements and a cover for the test element or other fluid source being acted upon by the probe. Suitable cassettes are described in U.S. Pat. Nos. 4,142,863 and 4,512,952, both incorporated by reference in their entireties.
Located within the cover is at least one opening, preferably two and more preferably three openings adapted to receive the probe tip. The opening(s) can include a surface that extends away from the opening and at least partially surrounds the opening(s). Preferably, the openings are round and the surface has at least a partially cylindrical shape. The surface can open in an increasing manner in a direction away from the hole toward the probe tip to assist in guiding the probe into registration with the test element. For example, the surface can have the shape of a truncated cone.
In one embodiment, there are a plurality of openings and one of the openings opens in a direction that is different than the other openings. This can be provided for a variety of reasons. For example, in some embodiments, there may be provided multiple probes, such as one for sample and the other for reference fluids for potentiometric analysis as described above, that are positioned at different angles with respect to the test element or other fluid sources. In this embodiment, the other opening can receive the probe in the same manner as the other opening that have an open perpendicular to the covering of the test element. It should be understood that the description of the plurality of holes above encompasses designs where the holes share common sectors with each other, such that there are no discontinuities between holes. That is, the holes overlap to a certain extent. This is illustrated in
The probe guide can be an integral or unitary one-piece construction with the holder, or a separate attached structure. In a preferred embodiment, the guide alone or the integral guide and holder are formed from an injection molded plastic. In some embodiments, the test elements may come pre-packaged in a disposable test element holder. In these embodiments, the probe guide may likewise be disposable, preferably recyclable. Of course, if the probe guide is separately attachable to the test element holder, it can be independently disposable. At least periodic disposal is particularly advantageous, because it dispenses with cleaning requirements, reduces the likelihood of carryover between samples, and reduces tolerance buildup.
In a preferred embodiment, a movable fluid supply of the analyzer that can be removably attached to the desktop analyzer is provided in conjunction with the stationary probe. The test element holder with the probe guide can be included with, and preferably in, the movable fluid supply. In a preferred embodiment, the test element holder sits in a recess of the movable fluid supply. The movable fluid supply can also include a probe tip holder and a fluid supply section and is preferably of a one-piece construction. The probe tip holder retains a tip that will be used to aspirate the fluid in the fluid supply section. The fluid supply section contains the fluid, such as whole blood, serum plasma, wash fluid, or a diluent to be aspirated and dispensed onto the test element. These can also be recesses in the movable fluid supply. Thus, in one unit, all components of the analyzer that are required to be in registration with the probe tip can be included in the fluid supply section
In another preferred embodiment of the invention, a plurality of test element holders with probe guides are provided. By providing a test element holder with a corresponding probe guide, different test elements, such as potentiometric and colorimetric test elements, or wet and dry test elements, can be used together on a single analyzer, providing a significant benefit in reducing size and providing optimum flexibility in analysis. Further details of multiple test element holders are described in copending application entitled “Test Element Holder with a Probe Guide for an Analyzer” filed concurrently herewith and incorporated by reference in its entirety.
Another embodiment of the present invention, which is significant in reducing size and providing optimum flexibility in analysis, involves the probe being stationary (as described above) and the test element(s) making all significant movements, such as by the rotors described below, to bring the test element and probe into the desired registration.
The materials of construction for the analyzer, including the probe guide, test element holder and movable fluid supply can include all suitable materials known in the art, such as plastic or metal. The disposable items of the analyzer, such as the test element holder and metering tips are preferably made from environmentally friendly, recyclable materials.
Another aspect of the invention provides a method of aspirating or dispensing a liquid, or more preferably performing an analysis on a sample, using the analyzer according to the present invention. In one preferred embodiment, the type of analysis or test to be performed on a sample is selected. Based on the test to be performed, one or more movable test elements, corresponding to the test to be performed, are loaded onto the analyzer, preferably in the movable liquid supply. The test elements preferably contain identification indicia or marks, such as a barcode, that can be read by the analyzer to determine the test to be performed and optionally the physical dimensions of the test element. In some instances the analysis to be performed is also inputted into the control system for the analyzer, preferably through a keyboard of a computer that controls the analyzer.
A sample is provided, preferably on the movable fluid supply. The movable fluid supply containing the sample and test elements is loaded onto the analyzer. Depending on the number and type of analysis to be performed, more than one movable fluid supply may be required. Upon activation of the analyzer, a transport system or conveyor moves the movable fluid supply into registration with the stationary probe. In some embodiments, a disposable probe tip is pre-loaded onto the movable fluid supply and the probe first receives the tip. The sample is then moved into registration with the probe and the probe aspirates sample into the tip. After aspirating the sample, the test elements are moved into registration with the probe. A pre-selected amount of the sample is dispensed from the probe tip onto or into the test element. If necessary, a supply of liquid reagent, such as horseradish peroxide oxidase (“HPO”), can be moved into registration with the stationary probe. The probe aspirates the reagent and retains the reagent until the sample has moved back into registration with the probe, at which point, the reagent is dispensed onto the test element containing the sample.
At this point, if incubation is required, the test element containing the sample, can be incubated. On those preferred embodiments that contain a dual-rotor configuration as described below, the test element can be transferred to the inner rotor and incubated, while the outer reagent rotor continues the function of transporting sample and test elements into registration with the stationary probe. After incubation, the sample can be optionally washed, once again, by moving a supply of liquid wash into registration with the stationary probe. After washing, the sample can be transferred to a spectrometer to have its signal read. On chemiluminscent applications where a signal reagent is needed, once again, a supply of signal reagent is moved into registration with the probe to be aspirated and then dispensed onto the washed sample. After completion of the analysis, the test element can be disposed of. In those embodiments that make use of an inner movable ring, the inner ring may be brought into registration with a waste container on the outer ring and ejected into the waste container. Likewise, the outer reagent rotor can rotate the waste container into alignment with the stationary probe and receive the used probe tip(s).
The present invention will now be illustrated in connection with the following detailed preferred embodiment. Of course, the preferred embodiment is intended for illustrative purposes only and is not intended to limit the scope of the invention.
In a preferred embodiment, the analyzer includes dual concentric rotors. Samples may be whole blood, which may be automatically centrifuged prior to metering, or a variety of other sample types including serum, plasma and urine, among others. The concentric rotors work in concert to process a wide variety of analytical tests with little intervention by the user.
The outer reagent rotor carries the movable fluid supply(ies) and eliminates the need for multiple system modules and associated complexity since it is capable of storing and processing samples, test elements, liquid reagents, disposables and waste on a single platform. The multifunctional outer reagent rotor allows the user to place multiple patient samples on the rotor in addition to individual, assay specific test slides in test cartridges. The movable fluid supply also accepts whole blood samples, which can be automatically centrifuged on the analyzer or prepared samples. The outer reagent rotor is also capable of positioning a variety of movable fluid supplies in various formats that allow for auto dilution of samples and expanded test menu capability through the addition of wash fluids for immuno rate assays. The reagent rotor is also capable of accepting a waste collection container to collect the various test slides and metering tips. The outer reagent rotor is automatically positioned to intersect a fixed metering system, that includes the fluid probe, used to aspirate and dispense various fluids.
The inner incubator rotor is used to incubate the slides at a predetermined temperature then position the slide for measurement by a sensitometry device, such as a reflectometer, electrometer or spectrometer. Test slides are then ejected from the incubator rotor into a common waste collection container placed on the reagent rotor. The waste collection container is also able to collect other test consumables such as disposable probe tips due to the random access positioning capability of the reagent rotor.
All test processing and waste collection is accomplished within the rotors. Additional system features not shown can include an integral printer, user interface keypad/display, electronics and cabinetry.
In the embodiment shown in the figures, the reagent rotor (1) orients movable fluid supplies (2) concentric to the rotational axis of the reagent rotor (1). The reagent rotor is rotated about its center axis by a motor with a sensor to determine exact positioning. The movable fluid supplies (2) are reusable and are accurately positioned on the reagent rotor using a locating feature (3), which in this embodiment is a peg that inserts into a hole (not shown) on the underside of the movable fluid supply (2) and anti-rotation feature (4), which in this embodiment is a recess that will accept a pin attached to the end of a spring-loaded latch (5). The movable fluid supplies (2) are held in place on the reagent rotor by spring-loaded latches (5) or other means that allow easy loading and unloading of the movable fluid supplies (2) by the user. A single disposable metering or probe tip (6) is placed in a recess on the top of the fluid supply (2) for access by the stationary probe system (16) that includes probe (24,
As shown in
As shown in
In a preferred embodiment, the methods described above can be implemented by a computer program interfacing with a computer, that can include a computer usable medium having computer readable program code configured to conduct the methods.
In another preferred embodiment, the analyzer is a veterinary analyzer that includes a T4 assay.
It will be apparent to those skilled in the art that various modifications and variations can be made to the compounds, compositions and processes of this invention. Thus, it is intended that the present invention cover such modifications and variations, provided they come within the scope of the appended claims and their equivalents.
The disclosure of all publications cited above are expressly incorporated herein by reference in their entireties to the same extent as if each were incorporated by reference individually.
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|39||U.S. Appl. No. 10/403,153, Tomasso, et al.|
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|U.S. Classification||422/64, 436/45, 422/72|
|International Classification||G01N35/04, G01N35/00, G01N35/10, G01N33/48, G01N35/02, G01N9/30|
|Cooperative Classification||G01N2035/0441, Y10T436/111666, G01N2035/0446, G01N2035/00138, G01N35/04, G01N2035/0443, G01N2035/0444|
|Sep 2, 2003||AS||Assignment|
Owner name: ORTHO-CLINICAL DIAGNOSTICS, NEW JERSEY
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:JAKUBOWICZ, RAYMOND FRANCIS;BARRY, JAMES VANSELOW;REEL/FRAME:014439/0541
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